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本文引用的文献

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Towards remote monitoring in pediatric care and clinical trials-Tolerability, repeatability and reference values of candidate digital endpoints derived from physical activity, heart rate and sleep in healthy children.迈向儿科护理和临床试验的远程监测——健康儿童的身体活动、心率和睡眠衍生的候选数字终点的耐受性、可重复性和参考值。
PLoS One. 2021 Jan 7;16(1):e0244877. doi: 10.1371/journal.pone.0244877. eCollection 2021.
2
Development of Novel, Value-Based, Digital Endpoints for Clinical Trials: A Structured Approach Toward Fit-for-Purpose Validation.开发新型、基于价值的临床试验数字化终点:一种有针对性的适合用途验证方法。
Pharmacol Rev. 2020 Oct;72(4):899-909. doi: 10.1124/pr.120.000028.
3
Technical validity and usability of a novel smartphone-connected spirometry device for pediatric patients with asthma and cystic fibrosis.一种新型智能手机连接式肺功能仪在哮喘和囊性纤维化患儿中的技术有效性和可用性研究。
Pediatr Pulmonol. 2020 Sep;55(9):2463-2470. doi: 10.1002/ppul.24932. Epub 2020 Jul 8.
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Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative.推进移动技术在临床试验中的应用:临床试验转化倡议的建议
Digit Biomark. 2019 Nov 6;3(3):145-154. doi: 10.1159/000503957. eCollection 2019 Sep-Dec.
5
The Future of Clinical Trial Design: The Transition from Hard Endpoints to Value-Based Endpoints.临床试验设计的未来:从硬性终点向基于价值的终点的转变。
Handb Exp Pharmacol. 2019;260:371-397. doi: 10.1007/164_2019_302.
6
Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative.儿科医生和家庭医生参与儿科临床试验的感知障碍:来自临床试验转型倡议的发现
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7
Wearable Devices in Clinical Trials: Hype and Hypothesis.可穿戴设备在临床试验中的应用:炒作与假设。
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Treatment of preschool children presenting to the emergency department with wheeze with azithromycin: A placebo-controlled randomized trial.阿奇霉素治疗因喘息到急诊科就诊的学龄前儿童:一项安慰剂对照随机试验。
PLoS One. 2017 Aug 3;12(8):e0182411. doi: 10.1371/journal.pone.0182411. eCollection 2017.
9
A qualitative study of sleep quality in children and their resident parents when in hospital.一项关于儿童及其住院陪护家长睡眠质量的定性研究。
Arch Dis Child. 2016 Jun;101(6):546-551. doi: 10.1136/archdischild-2015-309458. Epub 2016 Mar 24.
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Features and application of wearable biosensors in medical care.可穿戴生物传感器在医疗保健中的特点与应用
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急性儿科肺部疾病出院后的恢复情况可以通过数字生物标志物进行量化。

Postdischarge Recovery after Acute Pediatric Lung Disease Can Be Quantified with Digital Biomarkers.

机构信息

Centre for Human Drug Research, Leiden, The Netherlands.

Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands.

出版信息

Respiration. 2021;100(10):979-988. doi: 10.1159/000516328. Epub 2021 May 18.

DOI:10.1159/000516328
PMID:34004601
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8619741/
Abstract

BACKGROUND

Pediatric patients admitted for acute lung disease are treated and monitored in the hospital, after which full recovery is achieved at home. Many studies report in-hospital recovery, but little is known regarding the time to full recovery after hospital discharge. Technological innovations have led to increased interest in home-monitoring and digital biomarkers. The aim of this study was to describe at-home recovery of 3 common pediatric respiratory diseases using a questionnaire and wearable device.

METHODS

In this study, patients admitted due to pneumonia (n = 30), preschool wheezing (n = 30), and asthma exacerbation (AE; n = 11) were included. Patients were monitored with a smartwatch and a questionnaire during admission, with a 14-day recovery period and a 10-day "healthy" period. Median compliance was calculated, and a mixed-effects model was fitted for physical activity and heart rate (HR) to describe the recovery period, and the physical activity recovery trajectory was correlated to respiratory symptom scores.

RESULTS

Median compliance was 47% (interquartile range [IQR] 33-81%) during the entire study period, 68% (IQR 54-91%) during the recovery period, and 28% (IQR 0-74%) during the healthy period. Patients with pneumonia reached normal physical activity 12 days postdischarge, while subjects with wheezing and AE reached this level after 5 and 6 days, respectively. Estimated mean physical activity was closely correlated with the estimated mean symptom score. HR measured by the smartwatch showed a similar recovery trajectory for subjects with wheezing and asthma, but not for subjects with pneumonia.

CONCLUSIONS

The digital biomarkers, physical activity, and HR obtained via smartwatch show promise for quantifying postdischarge recovery in a noninvasive manner, which can be useful in pediatric clinical trials and clinical care.

摘要

背景

因急性肺部疾病住院的儿科患者在医院接受治疗和监测,之后在家中完全康复。许多研究报告了住院期间的恢复情况,但对于出院后完全康复所需的时间知之甚少。技术创新使人们对家庭监测和数字生物标志物产生了浓厚的兴趣。本研究旨在使用问卷和可穿戴设备描述 3 种常见儿科呼吸道疾病的家庭康复情况。

方法

在这项研究中,因肺炎(n = 30)、学龄前喘息(n = 30)和哮喘加重(AE;n = 11)而入院的患者被纳入研究。患者在入院期间使用智能手表和问卷进行监测,有 14 天的恢复期和 10 天的“健康”期。计算了中位依从性,并拟合了混合效应模型,以描述体力活动和心率(HR)的恢复期,体力活动恢复轨迹与呼吸症状评分相关。

结果

整个研究期间的中位依从性为 47%(四分位距[IQR] 33-81%),恢复期为 68%(IQR 54-91%),健康期为 28%(IQR 0-74%)。肺炎患者在出院后 12 天恢复正常体力活动,而喘息和 AE 患者分别在 5 天和 6 天达到该水平。估计的平均体力活动与估计的平均症状评分密切相关。智能手表测量的 HR 显示,喘息和哮喘患者的恢复轨迹相似,但肺炎患者的 HR 则不同。

结论

通过智能手表获得的数字生物标志物、体力活动和 HR 有望以非侵入性的方式定量评估出院后的恢复情况,这在儿科临床试验和临床护理中可能有用。